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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 26.06.2023
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Hemin (trade name Hemin) is an iron-containing porphyrin. More specifically, it is protoporphyrin IX containing a ferric iron ion (heme B) with a chloride ligand.
Hemin (Hemin for injection) is indicated for the amelioration of recurrent
attacks of acute intermittent porphyria temporally related to the menstrual cycle in
susceptible women.
Manifestations such as pain, hypertension, tachycardia, abnormal mental status
and mild to progressive neurologic signs may be controlled in selected patients with this
disorder.
Similar findings have been reported in other patients with acute intermittent
porphyria, porphyria variegata and hereditary coproporphyria. Hemin is not
indicated in porphyria cutanea tarda.
Hemin is made of red blood cells processed from human blood. Hemin works by lowering the production of a certain enzyme in the body.
Hemin is used to treat the symptoms of occasional attacks of porphyria related to the menstrual cycle in women. Hemin helps control symptoms such as pain, increased heart rate or blood pressure, and changes in mental status.
Hemin should not be used to treat porphyria that affects the skin, also called porphyria cutanea tarda.
Hemin is not a cure for porphyria. It will only control the symptoms of a porphyria episode.
Hemin may also be used for purposes not listed in this medication guide.
Before administering Hemin, an appropriate period of alternate therapy (i.e., 400 g glucose/day for 1 to 2 days) must be considered. If improvement is unsatisfactory for the treatment of acute attacks of porphyria, an intravenous infusion of Hemin containing a dose of 1 to 4 mg/kg/day of hematin should be given over a period of 10 to 15 minutes for 3 to 14 days based on the clinical signs. In more severe cases this dose may be repeated no earlier than every 12 hours. No more than 6 mg/kg of hematin should be given in any 24 hour period.
After reconstitution each mL of Hemin contains the equivalent of approximately 7 mg of hematin. The drug may be administered directly from the vial.
Dosage Calculation Table
1 mg hematin equivalent = 0.14 mL Hemin
2 mg hematin equivalent = 0.28 mL Hemin
3 mg hematin equivalent = 0.42 mL Hemin
4 mg hematin equivalent = 0.56 mL Hemin
Since reconstituted Hemin is not transparent, any undissolved particulate matter is difficult to see when inspected visually. Therefore, terminal filtration through a sterile 0.45 micron or smaller filter is recommended.
Preparation of Solution
Reconstitute Hemin by aseptically adding 43 mL of Sterile Water for Injection, USP, to the dispensing vial. Immediately after adding diluent, the product should be shaken well for a period of 2 to 3 minutes to aid dissolution. NOTE: Because Hemin contains no preservative and because Hemin undergoes rapid chemical decomposition in solution, it should not be reconstituted until immediately before use. After the first withdrawal from the vial, any solution remaining must be discarded.
No drug or chemical agent should be added to a Hemin fluid admixture unless its effect on the chemical and physical stability has first been determined.
How supplied
Hemin is supplied as a sterile, lyophilized black powder in single dose dispensing vials (NDC 67386-701-54). When mixed as directed with Sterile Water for Injection, USP, each 43 mL provides the equivalent of approximately 301 mg hematin (7 mg/mL). Store lyophilized powder at 20-25°C (68-77°F). See USP controlled room temperature.
Caution: The packaging (vial stopper) of this product contains natural rubber latex which may cause allergic reactions.
Manufactured by: APP Pharmaceuticals, Raleigh, NC 27616, U.S.A. For: Lundbeck, Deerfield, IL 60015, U.S.A. Revised: November 2012
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What is the most important information I should know about Hemin?
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Using too much Hemin could be harmful to your kidneys. Follow the directions on your prescription label.
You should not use this medication if you are allergic to Hemin.
Before using Hemin, tell your doctor if you are allergic to latex rubber.
Also tell your doctor if you take birth control pills, hormone replacement therapy, a blood thinner, steroids, or a barbiturate sedative.
Hemin is made from human blood and may contain viruses and other infectious agents that can cause disease. Although donated human blood is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
Before you start treatment with Hemin, your doctor may perform tests to make sure you are having an actual porphyria attack.
Hemin is usually given after other medicines to treat porphyria have been given for a certain amount of time.
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Using too much Hemin could harm your kidneys.
Hemin is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
For best results, start using Hemin at the first sign of a porphyria attack.
You may need to use Hemin once or twice per day for up to 2 weeks, depending on how your body responds to the medicine.
Hemin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.
Prepare your dose only when you are ready to give an injection
After mixing the powder with the diluent, shake the mixture for 2 to 3 minutes.
Give the injection right away after mixing. Do not save it for later use. Throw away any unused mixture after one use. The Hemin and diluent mixture does not contain a preservative.
While using Hemin, you may need frequent blood and urine tests.
Store at cool room temperature away from moisture and heat.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This medication is used to treat the symptoms that occur with certain blood disorders (porphyrias). Other treatments are recommended for trial before using Hemin, also called hematin.
Hemin is not a cure for porphyria. In some cases, this medication may relieve symptoms such as pain, high blood pressure, rapid heartbeat, or mental changes that may occur during an acute attack of porphyria. If you have any questions about the use of this medication, consult your doctor.
How to use Hemin intravenous
This medication should only be given in a hospital or clinic setting where you can be monitored closely. It is given by injection into a vein as directed by your doctor, usually once daily.
The dosage is based on your weight, medical conditions, and response to therapy.
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What other drugs will affect Hemin?
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: barbiturates (e.g., pentobarbital, phenobarbital), "blood thinners" (anticoagulants such as heparin, warfarin), corticosteroids (e.g., prednisone), estrogens.
Do not start or stop any medicine without doctor or pharmacist approval.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
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What are the possible side effects of Hemin?
Clinical Trials Experience
Phlebitis with or without leucocytosis and with or without mild pyrexia has occurred after administration of hematin through small arm veins.
Post-marketing Experience
Reversible renal shutdown has occurred with administration of excessive doses.
There have been post-marketing literature reports of thrombocytopenia and coagulopathy (including prolonged prothrombin time and prolonged partial thromboplastin time) in patients receiving Hemin. Iron overload and serum ferritin increased have also been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.